At Siemens Healthineers, we are passionate
about enabling healthcare professionals to deliver high quality patient care,
and to do so affordably. A leading global healthcare company, Siemens
Healthineers continues to strengthen our portfolio of medical imaging and
laboratory diagnostics, while adding new offerings such as managed services,
consulting, and healthcare IT services – as well as further technologies in the
growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations
that support better patient outcomes with greater efficiencies, giving
providers the confidence they need to meet the clinical, operational and
financial challenges of a changing healthcare landscape.

Job Description:

Position overview

The QA Engineer 4 is responsible for multiple cross functional quality
management system elements within the Siemens quality management team. Provide
support across Molecular departments and sites to facilitate an environment of compliance
and meeting business objectives. Strive to ensure that appropriate quality
management system practices are in place and followed throughout the
organization. The successful candidate will report in to the Quality System
Manager within the business function
Responsibilities
The position requires extensive knowledge on the disciplines within a medical
device QMS. This role requires the capability to effectively assist and ensure
a compliant quality management system through accurate and reliable documentation.
Must be able to work independently, interface effectively, and demonstrate a
high level of reliability, integrity, and personal accountability, as a member
of the Siemens quality management team. Primary responsibility for
leading internal audits and manages the Audit and CAPA program meeting MD/IVD
regulations.
• Manage the internal audit program by leading internal audits, timely audit
scheduling, and training to ensure regulatory compliance.
• Apply and exercise audit readiness skills and techniques within the
organization and participate in external regulatory audits as a member of the
Siemens quality management team.
• Be a leader in introducing, coaching, and coordinating business improvements
through training, new quality tool development, implementation, and authoring
or editing SOP’s.
• Interface within the CAPA database tool and cross functional department
representation to manage CAPA workflow, coordinate CAPA meetings, acquire and
report on CAPA KPI’s, and ensure on time processing and compliance to prevent
reoccurrence of non-conformities. SME for the CAPA program and interface with
CAPA owners to ensure on time and compliant CAPA records.
Requires BA/BS in related field
• 6-10 years’ experience with all elements of the medical device or IVDD
quality management system including extensive experience in the following
areas:
• Leading internal audits within a medical device/IVDD environment.
• Certified Lead Internal Auditor; with at least 3 years of leading internal
audits and developing site schedules; 5 years of experience taking part in
audits within a medical device or IVDD company
• Formulation from cross functional teams key process Indicators supporting
management review.
• Coordination, leading, and implementation of quality data base tools, SW
systems or EQMS technical solutions.
• Advanced proficiency with the Microsoft Office Suite required; metric and KPI
reporting.
• Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Microsoft
Project/scheduling, Metric/chart creation).
• Willingness to travel 10% required.
• Effective communication, collaboration, and strong technical writing skills.
• Experience authoring and presenting technical and/or QMS training to cross
functional departments.
Preferred Knowledge/Skills, Education, and Experience
• BS degree in Life Science strongly preferred.
• ASQ CQE/CSQE or equivalent
• 1-3 years’ experience with corrective action data base administration.
• Supplier assessment and approval through site audits.
• Six Sigma Certification preferred

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